Test instrument and optical measurement apparatus

ABSTRACT

It is an object to provide a test instrument and an optical measurement apparatus which enable easy matching of test results when tests by optical measurement are performed with respect to a large number of patients. 
     To the above end, a test instrument B is provided, which includes reagent retaining portions  8 A,  8 B,  8 C retaining a reagent which reacts with a sample to produce a color reaction. The test instrument B includes a patient information entry section  64  as an example of patient identifying information region in which patient identifying information is to be written.

TECHNICAL FIELD

The present invention relates to a test instrument for opticalmeasurement and an optical measurement apparatus for performing a testby reading the color development of a reagent of the test instrument.

BACKGROUND ART

Nowadays, various measurement apparatuses are used for POCT (Point ofCare Testing) to be performed at hospitals, clinics, homes, etc.,without relying on clinical examination specialists. Examples of suchapparatuses include clinical examination apparatuses (see e.g. PatentDocument 2) for performing optical reading with respect to an urine teststrip (see e.g. Patent Document 1) once dipped in urine, or with respectto a biochemical test piece to which blood serum or blood plasma hasbeen applied. Other examples are optical measurement apparatuses forperforming measurement with respect to a cuvette (see e.g. PatentDocument 3) with a liquid reagent contained.

FIG. 12 shows an example of conventional optical measurement apparatus(see e.g. Patent Document 4). To the illustrated optical measurementapparatus X, a test instrument Y for immunochromatography is mounted.The test instrument Y is a test piece in the form of a strip providedwith a porous carrier 91. The porous carrier includes a plurality ofreagent retaining portions 92 which retain a reagent (an immunologicsubstance, mainly antibodies) fixed to the portion. When a liquid samplesuch as blood or urine to be analyzed is applied to part of the testinstrument Y, the sample infiltrates into the porous carrier 91. Whenthe sample moving through the carrier reaches the reagent retainingportions 92, the sample reacts with the reagent. As a result, thereagent retaining portions 92 produces a color reaction in accordancewith the concentration of a particular component contained in thesample.

FIG. 13 shows a typical urine test strip to be used by dipping in urine.The illustrated test strip 910 includes a base 911 in the form of astrip, and reagent retaining portions 912. Each reagent retainingportion 912 is provided on the base 911 and includes a carrier made of aporous matrix such as filter paper in which a reagent is fixed in animpregnated and dried state. When the reagent retaining portion 912 ofthe test strip 910 is dipped in a urine sample collected in e.g. a papercup and pulled out, the urine sample infiltrated in the reagentretaining portion 912 through the carrier reacts with the reagent. Afterthe lapse of a predetermined reaction period, the color development ofthe reagent retaining portion 912 is checked.

FIG. 14 shows an example of conventional optical measurement apparatusfor the measurement of a biochemical test piece including a reagentretaining portion to which a sample of urine or blood serum/blood plasmaextracted from blood is to be directly applied. The illustrated opticalmeasurement apparatus 920 includes a table 922 on which biochemical testpieces 921 are to be mounted. Each test piece 921 includes a carriermade of at least one of a high polymer compound (e.g. paste representedby water-soluble polymer) and a porous film (such as knit fabric ornonwoven fabric). The reagent retaining portion is provided by fixing areagent to at least one of the high polymer compound and the porous filmin a dry state. To perform measurement using the optical measurementapparatus 920, a liquid sample such as blood or urine to be analyzed isdirectly applied to the reagent retaining portion of the test piece 921.The sample dissolves the high polymer compound forming the carrier orinfiltrates into the porous film. Thus, the sample reacts with thereagent in the reagent retaining portion. After the lapse of apredetermined reaction period, the color development of the reagentretaining portion is checked.

FIG. 15 shows an example of test instrument of a cuvette type. The testinstrument 930 shown in the figure includes a plurality of wells 931 andis made of e.g. a light-transmitting resin. Each of the wells 931 isused as a carrier, and a reagent retaining portion is provided bysealing a reagent in a liquid or solid state in the well 931. When asample is put into a selected one of the wells 931 of the testinstrument 930, the sample reacts with the reagent in the well 931.After a predetermined period of time, the well 931, which functions asthe reagent retaining portion, develops color in accordance with theconcentration of a particular component contained in the sample. Sincethe well 931 transmits light, the color development is easily checkedfrom the outside.

Referring again to FIG. 12, the optical measurement apparatus X includesa light emitting means 93 and a light receiving means 94. When the testinstrument Y is mounted to the optical measurement apparatus X, aninstruction to start the test is given to the controller 95 by e.g. theuser's operation. The controller 95 performs the light emittingoperation for lighting the light emitting means 93 and the lightreceiving operation for receiving the light reflected by the porouscarrier 91 including the reagent retaining portion 92 at the lightreceiving means 94. By the signal transmission from the light receivingmeans 94 to the controller 95, the image data of the reagent retainingportions 92 of the porous carrier 91 are stored in the controller 95. Byanalyzing the image data which corresponds to the color development ofthe reagent retaining portions 92, the presence or absence of aparticular component in the sample is determined.

Though not illustrated, when the test instrument Y is an urine teststrip similar to the test strip 910 shown in FIG. 13 or a biochemicaltest piece, the light reflection during or after the reaction of thesample with the reagent on the surface of the reagent retaining portion912 (sometimes called a reagent pad) is measured by an exclusive device.When the test instrument Y is of a cuvette-type similar to the testinstrument 930 shown in FIG. 15, the light reflection or lighttransmission after the reaction of the sample with the reagent in thewell is measured through the light-transmitting surface of the well.

The test results obtained by the optical measurement are outputted by anoutput means 96 such as a printer. Based on the output results, the usercan recognize the presence or absence of a particular component in thesample.

However, in the case of e.g. tests for influenza which are oftenperformed by immunochromatography, tests for many patients are performedin e.g. a hospital in a short period of time. Thus, it is necessary toproperly match each of the test results with the relevant patient. Thesame type of test piece Y is used for the same test item, and generally,the test result printed by the printer accompanies only the test timeand serial number, for example. Thus, when the tests are performed withrespect to many patients, the work to match each test result with thepatient is troublesome. Moreover, when the tests of a plurality of itemssuch as influenza and allergy are performed, the time required for thetests differs among the test pieces Y. In this case, to match theprinted test result with the test item or the patient is more difficult.

Patent Document 1: PCT W02006/059694

Patent Document 2: JP-A-09-127120

Patent Document 3: JP-A-2001-318101

Patent Document 4: JP-A-2006-250787

DISCLOSURE OF THE INVENTION Problems to be Solved by the Invention

The present invention has been proposed under the circumstancesdescribed above. It is, therefore, an object of the present invention toprovide a test instrument and an optical measurement apparatus whichenable easy matching of test results when tests by optical measurementare performed with respect to a large number of patients.

Means for Solving the Problems

According to a first aspect of the present invention, there is provideda test instrument comprising at least one reagent retaining portionretaining a reagent which reacts with a sample to produce a colorreaction. The test instrument includes a patient identifying informationregion in which patient identifying information is to be entered.

In a preferred embodiment of the present invention, the test instrumentfurther comprises a carrier to which a sample is to be applied, and theat least one reagent retaining portion comprises part of the carrierwhich retains the reagent.

In a preferred embodiment of the present invention, the test instrumentis a test piece for immunochromatography. The carrier comprises a porousfilm. The reagent retaining portion is provided by fixing an immunologicsubstance to the porous film. The patient identifying information regionis provided at part of the porous film.

In a preferred embodiment of the present invention, the test instrumentis a test piece for immunochromatography. The carrier comprises a porousfilm. The reagent retaining portion is provided by fixing an immunologicsubstance to the porous film. The test instrument further comprises acase accommodating the carrier and including a measurement windowexposing the reagent retaining portion. The patient identifyinginformation region is provided at part of the case.

In a preferred embodiment of the present invention, the test instrumentis a test strip to be dipped in a liquid. The carrier comprises a porousfilm. The reagent retaining portion is provided by fixing an immunologicsubstance in a dry state to the porous film. The test instrument furthercomprises a base to which the reagent retaining portion is bonded. Thepatient identifying information region is provided on the base.

In a preferred embodiment of the present invention, the test instrumentis a test piece which is so designed that a sample is to be dropped ontothe reagent retaining portion. The carrier comprises at least one of ahigh polymer compound and a porous film. The reagent retaining portionis provided by fixing the reagent in a dry state to at least one of thehigh polymer compound and the porous film. The test instrument furthercomprises a base to which the reagent retaining portion is bonded. Thepatient identifying information region is provided on the base.

In a preferred embodiment of the present invention, the test instrumentis a light-transmitting cuvette including a plurality of compartments.The carrier comprises a light-transmitting compartment. The reagentretaining portion is provided by sealing the reagent in a liquid orsolid state in the compartment. The test instrument further comprises asealing member for hermetically sealing the compartment. The patientidentifying information region is provided on the sealing member.

In a preferred embodiment of the present invention, the test instrumentis a light-transmitting cuvette including a plurality of compartments.The carrier comprises a light-transmitting compartment. The reagentretaining portion is provided by sealing the reagent in a liquid orsolid state in the compartment. The patient identifying informationregion is provided on a side surface of the light-transmittingcompartment.

In a preferred embodiment of the present invention, the patientidentifying information region is raised relative to the surroundingportion.

In a preferred embodiment of the present invention, the patientidentifying information region has a surface which is rougher than thesurface of the surrounding portion.

According to a second aspect of the present invention, there is providedan optical measurement apparatus to be used with at least one testinstrument according to the first aspect of the present inventionmounted to the apparatus. The optical measurement apparatus comprises areader for reading color development of the reagent retaining portion,and a controller for performing drive control of the reader and testprocessing. The reader is capable of reading the patient identifyinginformation region. The controller generates test result output datausing the image data of the patient identifying information regionobtained by the reading operation of the reader.

In a preferred embodiment of the present invention, the opticalmeasurement apparatus further comprises a printer as output means. Theprinter performs printing based on the test result output datatransmitted from the controller.

In a preferred embodiment of the present invention, the opticalmeasurement apparatus further comprises an external connector as outputmeans. The controller is capable of transmitting the test result outputdata through the external connector.

In a preferred embodiment of the present invention, the opticalmeasurement apparatus is so designed that a plurality of said testinstruments can be mounted.

Other features and advantages of the present invention will become moreapparent from the detailed description given below with reference to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an overall perspective view showing an example of testinstrument according to the present invention.

FIG. 2 is a plan view of the test instrument shown in FIG. 1.

FIG. 3 is a sectional view taken along lines III-III in FIG. 2.

FIG. 4 is a sectional view taken along lines IV-IV in FIG. 2.

FIG. 5 is a sectional view taken along lines V-V in FIG. 2.

FIG. 6 is an overall perspective view showing an example of opticalmeasurement apparatus according to the present invention.

FIG. 7 is a system structure diagram of the optical measurementapparatus shown in FIG. 6.

FIG. 8 is a chart showing an example of test using the opticalmeasurement apparatus shown in FIG. 6.

FIG. 9 is a plan view of the sheet showing the results of the test ofFIG. 8.

FIG. 10 is a chart showing another example of test using the opticalmeasurement apparatus shown in FIG. 6.

FIG. 11 is a plan view of the sheet showing the results of the test ofFIG. 10.

FIG. 12 is a system structure diagram of an example of conventionaloptical measurement apparatus and test piece.

FIG. 13 is a perspective view showing an example of conventional testinstrument of a test strip type.

FIG. 14 is a perspective view showing an example of conventional opticalmeasurement apparatus.

FIG. 15 is a sectional view showing an example of conventional testinstrument of a cuvette type.

BEST MODE FOR CARRYING OUT THE INVENTION

Preferred embodiments of the present invention will be described belowwith reference to the accompanying drawings.

FIGS. 1-5 show an example of test instrument according to the presentinvention. The test instrument B of this embodiment includes a case 6, acarrier 7 and reagent retaining portions 8A, 8B, 8C to which animmunologic substance such as an antibody is fixed. As will be describedlater, the test instrument is to be mounted to an optical measurementapparatus such as an apparatus for immunochromatography and used for theoptical measurement by immunochromatography. Specifically, the testinstrument B may be used for the tests for influenza.

The case 6 comprises a base 6B and a cover 6A elongated and made of e.g.a white resin and accommodates the carrier 7 made of a porous matrix.The case 6 includes an application portion 61, a measurement window 62,a test item code 63 and a patient information entry section 64 and isformed with a dented portion 6 a and an inclined surface 6 b.

The application portion 61 is a portion to which a sample is applied.The application portion comprises a through-hole formed in the cover 6Ato expose an end of the carrier 7 and a crater-shaped portionsurrounding the through-hole. The measurement window 62 comprises anelongated through-hole formed at the center of the cover GA and exposesthe reagent retaining portions 8A, 8B, 8C formed at the carrier 7. Thetest item code 63, which may be a printed barcode (a two-dimensionalcode in the illustrated example), is provided for indicating the testitem that can be tested by the test instrument B.

The patient information entry section 64 is a region in whichinformation such as the name of the patient taking the test is to bemanually written. The patient information entry section is an example ofpatient identifying information region in the present invention. Asshown in FIGS. 2 and 4, the patient information entry section 64 in thisembodiment is in the form of a rectangular platform raised relative tothe surrounding portions. As shown in FIG. 5, the surface of the patientinformation entry section 64 is grained and rougher than the surfaces ofother portions. In the patient information entry section of theillustrated example, the name of the patient who provided the sample forthe test with the test instrument B is handwritten by the patienthimself or herself or the user, i.e. a nurse or a clinical laboratorytechnologist for example, using a writing tool such as a felt-tip pen.Although it is assumed that the name of the patient is to be written inthe patient information entry section 64, any other information such asthe identification number of the patient in the organization to whichthe patient belongs to or the patient's nickname may be written as longas the given information can identify the patient.

The measurement window 62 is provided at the dented portion 6 a. Asshown in FIG. 3, the dented portion 6 a is closer to the carrier 7 thanthe portions sandwiching the dented portion 6 a in the longitudinaldirection of the case 6 are. In this embodiment, the test item code 63is applied to the dented portion 6 a to adjoin the measurement window 62in the width direction of the case 6. The inclined surface 6 b isconnected to the measurement window 62 in the width direction of thecase 6. In this embodiment, the inclined surface 6 b is inclined 45degrees with respect to the width direction of the case 6.

Though not illustrated, when the test instrument B is a urine teststrip, the test instrument includes a base and reagent retainingportions 8A and 8B formed on the base. In this case, each of the reagentretaining portions 8A and 8B is structured as a reagent pad provided byimpregnating and drying a reagent in a carrier. The reagent retainingportions are designed for the testing of a plurality of items such thatthe reagent retaining portion 8A is for testing glucose while thereagent retaining portion 8B is for testing protein, for example. A testitem code 63 is printed on the support to show what kind of items thetest instrument B measures.

When the test instrument B is of a cuvette type, each of thecompartments (hereinafter referred to as “well”) in the cuvettecorresponds to the carrier 7. By sealing a reagent in a liquid or solidstate in the wells, the wells function as reagent retaining portions 8Aand 8B. A test item code 63 may be printed on the surface of an aluminumlaminate which hermetically seals the well to prevent the content fromleaking out of the well. A patient information entry section 64, whichis an example of patient identifying information region, may also beprovided on the surface of the seal. Alternatively, the patientinformation entry section 64 may be provided on the side surface of awell which is not directly related to the optical measurement. Forinstance, the patient information entry section may be provided on theside surface of a well for holding a pipette tip (the well on the rightend in FIG. 15) or a well for storing waste liquid after the use for themeasurement.

In a test instrument B for immunochromatography, the carrier 7 is aporous member for causing the sample applied to the application portion61 to spread over the reagent retaining portions 8A, 8B and 8C and maycomprise a strip made of e.g. nitrocellulose. In a urine test strip, abiochemical test piece or a cuvette-type test instrument, the carrier 7is a pad made of at least one of a porous film and a high molecularcompound impregnated with a reagent or a well constituting the cuvette.

In this embodiment which employs immunochromatography as an example, thereagent retaining portions 8A, 8B, 8C are provided by fixing a reagent(immunologic substance such as an antibody) to part of the carrier 7.Specifically, the reagent retaining portions 8A and 8B are provided byfixing e.g. a reagent for determining positive or negative in tests forinfluenza. The reagent retaining portions 8A and 8B extend linearly inthe width direction of the carrier 7 and are generally called a “testline”. The number of reagent retaining portions 8A and 8B may beincreased as desired depending on the target to be tested. Althoughthese reagent retaining portions are generally called “test line”, theymay not be linear but may be in the form of a spot. In a urine teststrip, the reagent retaining portion 8A is a reagent pad for testing asingle item. Theoretically, therefore, when a urine test strip includesten reagent retaining portions, the urine test strip is capable oftesting ten items.

The reagent retaining portion 8C is utilized for determining whether ornot the sample has properly passed through the reagent retainingportions 8A and 8B, which are the test lines, and is generally called a“control line”. The reagent retaining portion 8C is provided by fixinge.g. a reagent which develops color due to the reaction with a sampleand extends linearly in the width direction of the carrier 7. Unlikethis, when the test instrument is an urine test strip or a cuvette-typetest instrument, a reagent may not be put into the reagent retainingportion 8C so that the reagent retaining portion can be utilized as acontrol pad or a control well for optically canceling the influence ofhemolysis or dark colored urine caused by taking a medicine, forexample.

FIGS. 6 and 7 show an example of optical measurement apparatus accordingto the present invention. The optical measurement apparatus A of thisembodiment includes a case 1, a reader 2, a controller 3, a printer 4and an external connector 5. The apparatus is designed to perform animmunochromatography test by checking the color development of the testinstrument B mounted to the apparatus. In FIG. 7, the illustration ofthe case 1 is omitted for easier understanding.

As shown in FIG. 6, the case 1 of the optical measurement apparatus A,which may be made of e.g. a resin or a metal, accommodates the reader 2,the controller 3, the printer 4 and the external connector 5, which arethe other structural elements of the optical measurement apparatus A.The case 1 includes a mount portion 11. A test instrument B to which asample is applied is to be mounted to the mount portion 11. In thisembodiment, the mount portion 11 is made up of six sections CH1-CH6 sothat six test instruments B at the most can be mounted at a desiredtiming. A plurality of LED lamps are provided directly above the mountportion 11. When a test instrument B is mounted to the mount portion 11at a position directly below one of the LED lamps, the LED lamp emitslight of a predetermined color to indicate the mounting of the testinstrument. When the test of the test instrument B is completed, the LEDlamp emits light of a predetermined color to indicate the completion ofthe test. As shown in FIG. 7, six sensors 12 are provided at the mountportion 11. The sensors 12 are utilized for determining to which of thesections CH1-CH6 the test instrument B is mounted.

As shown in FIG. 7, the reader 2 includes light emitting modules 21A,21B, 21C and light receiving sensor modules 22A, 22B. The light emittingmodules 21A, 21B and the light receiving sensor module 22A are utilizedfor reading the reagent retaining portions 8A, 8B, 8C through themeasurement window 62 of the test instrument B and reading the test itemcode 63. The light emitting module 21C and the light receiving sensormodule 22B are utilized for reading the patient information entrysection 64. In the reader 2, the light emitting modules 21A, 21B, 21Cand the light receiving sensor modules 22A, 22B may be supported anddriven collectively. Alternatively, for instance, the light emittingmodules 21A, 21B and the light receiving sensor module 22A may besupported and driven separately from the light emitting module 21C andthe light receiving sensor module 22B. Unlike this embodiment, all ofthe reagent retaining portions 8A, 8B, 8C, the test item code 63 and thepatient information entry section 64 may be read by a single lightreceiving sensor module 22A. In this case, the light receiving sensormodule 22A may be designed to have a relatively wide light receivingarea.

The light emitting modules 21A and 21B incorporate e.g. LEDs and emitlight of different wavelengths. Each of the light emitting modules 21Aand 21B emits linear light extending in the longitudinal direction ofthe test instrument B. The light receiving sensor module 22A may includea plurality of photodiodes arranged in a row or an optical sensor suchas an area sensor and generates an output corresponding to the luminanceof the received light. The light receiving area of the light receivingsensor module 22A is in the form of a narrow strip extending in thelongitudinal direction of the test instrument B. In this embodiment,when the reader 2 is positioned directly above a test instrument B, thelight receiving sensor module 22A faces the measurement window 62 andthe light emitting modules 21A and 21B emit light toward the measurementwindow 62 at an angle of about 45 degrees from the opposite sides of thelight receiving sensor module 22A. By selectively irradiating thereagent retaining portions 8A, 8B, 8C with light of differentwavelengths from the light emitting modules 21A and 21B, the reagentretaining portions can be read as image data of at least two kinds ofcolor phases.

The light emitting module 21C incorporates e.g. an LED and emits lightof a predetermined wavelength. Specifically, the light emitting module21C emits linear light extending in the longitudinal direction of thetest instrument B. The light receiving sensor module 22B may include aplurality of photodiodes arranged in a row or an optical sensor such asan area sensor and generates an output corresponding to the luminance ofthe received light. The light receiving area of the light receivingsensor module 22B is in the form of a narrow strip extending in thelongitudinal direction of the test instrument B. In this embodiment,when the reader 2 is positioned directly above a test instrument B, thelight receiving sensor module 22B faces the patient information entrysection 64 and the light emitting module 21C emits light toward thepatient information entry section 64 at an angle of about 45 degrees.

The reader 2 is reciprocally movable directly above the six testinstruments B mounted to the mount portion 11. Specifically, the readeris slidably supported by a guide bar (not shown) extending in thedirection in which the six test instruments B are arranged and driven bya driving means such as a motor, a pulley or a belt (all not shown).When the reader 2 reciprocates directly above the six test instrumentsB, the light emitting modules 21A, 21B and the light receiving sensormodule 22A read the reagent retaining portions 8A, 8B, 8C and the testitem code 63 of the six test instruments B alternately. At the sametime, the light emitting module 21C and the light receiving sensormodule 22B successively read the patient information entry sections 64of the six test instruments B. Even when only five or less testinstruments B are mounted to the mount portion 11, the reader 2 properlyperforms the reading operation with respect to the mounted testinstruments B. The arrangement of the test item code 63 and the patientinformation entry section 64 relative to the measurement window 62 maybe varied. For instance, the position of the test item code 63 and thatof the patient information entry section 64 may be switched. When such atest instrument B is to be used, the light receiving sensor module 22Amay read the reagent retaining portions 8A, 8B, 8C and the patientinformation entry section 64, whereas the light receiving sensor module22B may read the test item code 63.

For instance, the controller 3 includes a CPU, a ROM, a RAM and aninterface. The CPU controls the entirety of the optical measurementapparatus A. The ROM stores various programs or parameters for theprocessing to be performed by the CPU. The RAM temporarily storesprograms or measurement results. The interface performs the inputtingand outputting operations of the controller 3. In this embodiment, thecontroller 3 generates test result output data utilizing the testresults obtained by analyzing the image data obtained from the lightreceiving sensor module 22A, and the image data obtained from the lightreceiving image sensor module 22B. The test result output data istransmitted to the printer 4.

The printer 4 is a device for outputting the test results of the testinstrument B based on the test result output data transmitted from thecontroller 3. For instance, the printer incorporates a thermalprinthead. As shown in FIG. 9, when the test of the test instruments Bis completed in the immunochromatography apparatus A, the test resultscorresponding to the test item are printed.

The external connector 5 is a terminal for transmitting the test resultoutput data to the outside of the optical measurement apparatus A andenables serial communication in conformity to e.g. RS-232C. Aninformation processor such as a personal computer Pc is connected to theexternal connector 5. The personal computer Pc displays the test resultoutput data transmitted through the external connector 5 on the displayor records the test result output data in an internal memory or arecording medium.

The test using the optical measurement apparatus A will be describedbelow using tests for influenza by immunochromatography as an example.

EXAMPLE 1

FIG. 8 shows an example of test performed using the optical measurementapparatus A. In this figure, the horizontal axis indicates time, andeach of the reaction progress curves Cv indicates the progress ofreaction in a relevant one of the test instruments B mounted to thesections CH1-CH6. The reference level Lv represented by the dotted linesin the figure indicates the degree of progress of reaction above whichthe determination is possible. The single-dashed lines in the figureindicate the route of the reciprocal movement of the reader 2 over thesections CH1-CH6. In this example, tests for influenza are performedwith respect to six patients. Specifically, samples taken from sixpatients are applied to the respective test instruments B, and the testinstruments B are successively mounted to the mount portion 11. In eachof the six test instruments B, the name of the patient is written in thepatient information entry section 64.

First, the test instrument B to which sample is firstly applied ismounted to the section CH1 of the mount portion 11. The sensor 12detects the mounting of this test instrument and transmits a mountsignal to the controller 3. When the reader 2 passes above the testinstrument B in the section CH1 for the first time, the reader performsa reading operation Pf to read the test item code 63. In accordance withthe test item represented by the test item code 63, the controller 3sets a reaction completion period Tr1 for the section CH1. After themounting of the test instrument to the section CH is detected by thesensor 12, the reader 2 performs a reading operation Pt for reading thereagent retaining portions 8A, 8B, 8C a plurality of times, i.e., everytime it passes over the section CH1 until the reaction completion periodTr1 lapses. In this reading operations Pt, reading of the reagentretaining portions 8A, 8B, 8C is repeated. In this example, however, theresults of the reading operation performed during the reactioncompletion period Tr1 are not used for the determination. Instead, theresult of the reading operation P for reading the reagent retainingportions 8A, 8B, 8C which is performed for the first time after thelapse of the reaction completion period Tr1 is used for thedetermination of the influenza test. At the time point of the readingoperation P, the reaction progress curve Cv is higher than the referencelevel Lv, because the reaction completion period Tr1 has lapsed afterthe mounting of the test instrument B to the section CH1.

While the test processing for the section CH1 is performed in theabove-described manner, the test processing for the sections CH2-CH6 isalso performed. In this example, the test item is the same for all thetest instruments B in the sections CH1-CH6, so that reaction completionperiods Tr1-Tr6 are the same. Thus, the reading operation is performedsuccessively with respect to the sections CH1-CH6 in the order ofmounting. The controller 3 generates test result output data for each ofthe sections CH1-CH6 based on the test item and test result of each testinstrument B and the image data obtained by reading the patientinformation entry section 64. As shown in FIG. 9, the test result outputdata is successively printed by the printer 4. The content to be printedincludes the date and time, the identification number, the mount section(any of CH1-CH6), the test item, the test result and the name written inthe patient information entry section 64. As for the patient's name, theimage data of the patient information entry section 64 read by the lightreceiving sensor module 22B of the reader 2 is printed. To achieveclearer printing, the image data of the patient information entrysection 64 may appropriately be subjected to image processing such asbinarization by the controller 3.

EXAMPLE 2

FIG. 10 shows still another example of the test performed using theoptical measurement apparatus A. In this example, the program executedby the controller 3 is different from that of the above-describedexample. According to this program, preliminary determination isperformed using the result of a reading operation Pt performed beforethe reaction completion period Tr1-Tr6 lapses after the mounting of thetest instrument B.

Specifically, in this example, the preliminary determination isperformed with respect to the section CH2 based on the result of thereading operation Pt performed after the reading operation Pf. Thereaction progress curve Cv of the section CH2 is steeper than thetypical reaction progress curve Cv (indicated by double-dashed lines inthe figure). This indicates that the sample applied to the testinstrument B in the section CH2 is reacting with the reagent at a higherspeed than the normal. Thus, by the preliminary determination based onthe result of the second reading operation Pt, it is found that thereference level Lv is already exceeded. Then, the controller 3determines that the reaction in the test instrument B is completedbefore the lapse of the reaction completion period Tr2 and causes theprinter 4 to perform printing. That is, the second reading operation Ptcorresponds to the above-described reading operation P. Thus, thecontroller 3 finishes the test processing for that test instrument B.

FIG. 11 shows an example of printed test results of this example. Inthis example, six test instruments are mounted in the order of CH1-CH6.However, since the test processing of the test instrument B mounted tothe section CH2 is completed by the above-described preliminarydetermination, the result of the section CH2 is printed prior to theresult of the section CH1.

The advantages of the optical measurement apparatus A and testinstrument B will be described below.

According to the embodiment, the printer 4 prints the test resulttogether with the name of the patient. Thus, even when the tests areperformed successively with respect to a plurality of patients, thematching of the test result with the patient is easy.

A plurality of test instruments B can be mounted to the opticalmeasurement apparatus A. Once the test instruments B are mounted, thedetermination is made automatically after the lapse of the reactioncompletion period Tr1-Tr6 which is determined depending on the testitem. Thus, the user of the optical measurement apparatus A does notneed to perform time control from the time when the sample is applied toeach test instrument B until the time when the determination ispossible. This is suitable for such tests as influenza tests which areusually performed for a large number of patients in a short period oftime. Since each of the test results accompanies the patient's name,such a situation that the test result of one patient is erroneouslydetermined to be the result of another patient is prevented.

According to the test algorism of Example 2, for the test instrument Bin which the reaction of the sample with the reagent progresses fasterthan the expected speed, the test processing is finished before thelapse of the reaction completion period Tr2. Thus, the time taken forthe test processing of the test instrument B is reasonably reduced. Whenthe test of a certain test instrument is completed earlier than normalby the preliminary determination, the printing order of the test resultsof the plurality of test instruments B may differ from the expectedorder, i.e., the mounting order of the test instruments B. According tothis embodiment, however, the name or the like of the patient written inthe patient information entry section 64 is printed with the testresult. Thus, even when the test results are printed in an order whichis different from the expected order, the matching of each test resultwith the patient is properly performed. For instance, when an influenzatest and an allergy test are to be performed collectively, the reactioncompletion periods Tr1-Tr6 for the sections CH1-CH6 may differ from eachother. In such a case again, the order in which the test is completed,i.e., the printing order may differ from the mounting order. However,since each of the test results is printed together with the name or thelike of the patient written in the patient information entry section 64,the matching of each test result with the patient is easily performed.

The patient information entry section 64 of the test instrument B israised like a platform. Thus, the user or patient is prevented fromerroneously writing his or her name at a portion other than the patientinformation entry section 64. Further, since the patient informationentry section 64 has a relatively rough grained surface, writing usinge.g. a felt-tip pen is easy.

The test piece and optical measurement apparatus according to thepresent invention are not limited to the foregoing embodiments. Thespecific structure of each part of the test piece and opticalmeasurement apparatus according to the present invention may be variedin design in many ways. For instance, the number of the reagentretaining portions 8A, 8B, 8C is not limited to three, and a largernumber of reagent retaining portions may be provided.

The patient information entry section 64 is not limited to a rectangularone but may have any shape as long as it enables easy writing of thepatient's name or other patient identifying information. Instead ofmaking the surface of the patient information entry section 64 a grainedsurface, a white paint suitable for absorbing ink may be applied to thesurface. Although to raise the patient information entry section 64 isdesirable for preventing the writing out of the section, the test pieceof the present invention is not limited to this arrangement. Forinstance, the patient information entry section 64 may be a regiondefined by a boundary marked on a flat surface.

The reader 2 is not limited to such a structure that the light emittingmodules 21A, 21B and the light receiving sensor module 22A performscanning operation integrally with the light emitting module 21C and thelight receiving sensor module 22B. For instance, the light emittingmodule 21C and the light receiving sensor module 22B for reading thepatient information entry section 64 may perform scanning operationindependently from the light emitting modules 21A, 21B and the lightreceiving sensor module 22A. Further, the reader 2 does not necessarilyneed to include the light emitting module 21C and the light receivingsensor module 22B for exclusively reading the patient information entrysection 64, and at least any of the light emitting modules 21A, 21B andthe light receiving sensor module 22A may be utilized also for readingthe patient information entry section 64. As the output means, either ofthe printer 4 and the external connector 5 may be selectively provided.The optical measurement apparatus A may include a liquid crystal displayfor showing the test result output data. The test instrument and opticalmeasurement apparatus of the present invention are not limited to theuse for the tests for influenza and may be used for various tests usingimmunochromatography and various kinds of optical measurement.

1. An optical measurement apparatus to which at least one testinstrument is set, comprising: the test instrument comprising: at leastone reagent retaining portion retaining a reagent which reacts with asample to produce a color reaction; and a patient identifyinginformation region for entering patient identifying information, and theoptical measurement apparatus comprising: a reader for reading colordevelopment of the reagent retaining portion; a controller forperforming drive control of the reader and test processing; and aprinter for data output, wherein the reader is configured to read thepatient identifying information region, wherein the controller generatestest result output data using image data of the patient identifyinginformation region obtained by the reading operation or the reader, andwherein the printer performs printing based on the test result outputdata transmitted from the controller, and said printing includes anexact copy of images put in the patient identifying information region.2. The optical measurement apparatus according to claim 1, furthercomprising an external connector for data output; wherein the controlleris configured to transmit the test result output data through theexternal connector.
 3. The optical measurement apparatus according toclaim 1, wherein the optical measurement apparatus is configured toallow setting of a plurality of said test instruments thereto.